The Court of Appeal has today comprehensively dismissed an appeal by two pharmaceutical companies which challenged a policy adopted by 12 NHS clinical commissioning groups recommending the use of Avastin (bevacizumab) for intravitreal administration such as in the treatment of wet AMD, a chronic eye disorder that causes blurred vision or a blind spot in the visual field.
Responding to today’s ruling, Julie Wood, chief executive of NHS Clinical Commissioners said:
“The Court of Appeal’s clear ruling that the twelve northern CCGs acted lawfully in introducing the preferred treatment option for Avastin is some much-needed good news which will have significant benefits for the NHS.
“CCGs across the country have so far been unable to introduce the cheaper but equally effective drug Avastin for the treatment of wet AMD, so the finding that it is lawful for CCGs and clinicians to determine whether Avastin is clinically effective and safe for ophthalmic use in local areas will bring relief to many. The ruling also upheld the wider principle that cost considerations can be taken into account where there is no difference in clinical efficacy and safety of two or more medicines.
“The potential cost savings from switching to Avastin, with no impact on patient outcomes, remain significant, especially at this time of national crisis when resources in the NHS are so stretched. This ruling follows very considerable hard work from CCGs in the North East, which has been supported by NHSCC since 2015. We are very grateful to those CCGs for remaining true to their beliefs that it was the right and lawful thing to do for their patients and populations in spending the NHS pound to best effect, and fighting on behalf of all CCGs.”
Avastin is not currently licensed for the treatment of wet AMD, but guidance released by the National Institute for Health and Care Excellence (NICE) in January 2018 concluded that there are “…no clinically significant differences in effectiveness and safety…” between Avastin and the current market authorised medicines, ranibizumab (Lucentis) and aflibercept (Eylea) for the treatment of this condition. Furthermore, Avastin is the most cost-effective treatment compared to the others available, with the potential to release millions of pounds of vital funding locally which can be reinvested in other frontline NHS services.
In early 2018, following the release of the NICE guidance we worked with the GMC to clarify their position regarding the use of off-label medicines and fitness to practice processes.
In September 2019 the MHRA revised its position on the use of Avastin (bevacizumab) for intravitreal administration such as in the treatment of wet AMD, which accepted that “when prescribed and/or used by a healthcare professional, this does not create an unlicensed medicine and falls under the scope of ‘off-label’ use.”
In September 2018, a Judicial Review ruled that a group of CCGs in the North East acted lawfully in introducing the preferred treatment option for Avastin. The pharmaceutical companies which produce Lucentis and Eylea appealed the decision; the appeal was today rejected by the Court of Appeal.
25 March 2020